DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/15/2023, were in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS documents were considered. A signed copy of Form PTO-1449 is enclosed herewith.
Priority
This U.S. Application filed on 12/15/2023, is a CON of U.S. Application No. 17/117,559, filed on 12/10/2020 (ABN), which is a CON of U.S. Application No. 15/726,497, filed on 10/06/2017 (ABN), which is a CON of U.S. Application No. 15/348,348, filed on 11/10/2016 (U.S. Patent No. 9,877,961), which is a DIV of U.S. Application No. 13/688,442, filed on 11/29/2012 (U.S. Patent No. 9,522,892), which claims priority to U.S. Provisional Application Nos:
i) 61/666,291, filed on 06/29/2012;
ii) 61/641,698, filed on 005/02/2012;
iii) 61/614,292, filed on 03/22/2012; and
iv) 61/564,559, filed on 11/29/2011.
Status of the Claims
Claims 1-2, 4-5, 16-21 and 36-42 are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4-5, 16-21, 36-37 and 40-41 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 2, 4-5, 16-21 and 36-37 depend from claim 1 and are therefore, also rejected under 35 USC 112, second paragraph for the reasons set forth below.
Claims 1-2 recites the limitation “a reactive functional group that can form a bond with to X and X’, when present or to Y and Y’”, however, a person skilled in the art cannot reasonably determine the meets and bounds of the recited limitation. The term “a reactive functional group”, is not defined by the claim or the specification. The specification does not provide a standard for ascertaining the requisite degree. Thus, one of ordinary skill in the art would not be able to draw a clear boundary between what is and is not covered by the claims.
The scope of “a reactive functional group that can form a bond with to X and X’, when present or to Y and Y’”, is vague in that it is unclear as to what functional group would be considered as:
a) “a reactive functional group that can form a bond with to X and X’, when present or to Y and Y’”; or
b) “a reactive functional group that cannot form a bond with to X and X’, when present or to Y and Y’”; and
what functional group would not be considered as “a reactive functional group”.
Furthermore, the variable A as depicted in the compound of formula I, can only form a bond to L and L’. Appropriate correction is required.
Claim 1 recites “the substituted functional group”, in line 7. There is insufficient antecedent basis for this limitation in the claim. Claim 1 lacks antecedent basis because the preamble of claim 1 fails to recite “a substituted functional group”. Appropriate correction is required.
Claim 4 recites “linker L to Y and linker L’ to Y’”, in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 4 lacks antecedent basis because claim 1 from which claim 4 depends fails to recite “linker L to Y and linker L’ to Y’”, in a compound of formula I. Claim 1 recites “linker M to Y and linker M’ to Y’”. Appropriate correction is required.
Claims 40-41 are rendered indefinite reciting the limitation “the protecting group is hydrogen”, because hydrogen is not a protecting group in synthetic organic chemistry. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 5 and 16-20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nakagawa et al (hereinafter, “Nakagawa”, U.S. 20100093973, published 04/15/2010).
Independent claim 1 is drawn to a compound of formula I:
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34
369
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.
Regarding claims 1 and 5, Nakagawa (see Example 17), teaches di-ornithine spermine compound:
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200
400
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, which is a compound of formula I, wherein: A = C4 linear diamine; L = L’ = C3 alkyl linker; X = X’ = amide; M = M’ = C4 alkyl linker; and Y = Y’ = NH2. The compounds of the invention exhibit inhibitory effect on the absoprtion of phosphorus (see abstract and ¶s 0840-0841).
Regarding claim 16, Nakagawa teaches a pharamaceutical composition comprising compound Example 17 (see ¶s 0840-0841).
Regarding claims 17-20, Nakagawa teaches that compounds of the invention can be administered orally or by injection (see ¶ 0838).
Non-Statutory Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
U.S. Patent No. 9,522,892
Claims 1-2, 4-5, 16-21 and 36-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,522,892 (‘892 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and claims of the ‘892 patent are similarly drawn to a compound of formula I. For example, the claims of the instant application are drawn to a compound of formula I (claims 1-2, 4-5, 16-20 and 36-37), a method for using a compound of formula I (claims 21) and a method for making diarginine piperazine (claims 38-42), whereas, the claims of the ‘892 patent are directed to a piperazine compound of formula II, which is the same compound recited in instant claim 38 (see claim 6 of ‘892 patent).
Although the ‘892 patent is not explicit in claiming, for example, a compound of formula I, wherein A = a substituted piperazine, the claimed invention would have been obvious over the ‘892 application. This is because the ‘892 patent teaches a compound of formula I, wherein, A can be a substituted piperazine (see column 3) and teaches the compounds as anticoagulant reversal compounds (see abstract).
A patent’s "disclosure may be used…to answer the question whether claims merely define an obvious variation of what is earlier disclosed and claimed." AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 112 USPQ2d 1001, 1012 (Fed. Cir. 2014) (quoting In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
In the instant case, since the ‘892 patent discloses a compound of formula I, wherein A can be a substituted piperazine, as anticoagulant reversal compound (see discussions above), these aspects of the instant claims are, therefore, obvious over the ‘892 patent.
The AbbVie court explicitly noted that the Federal Circuit has “repeatedly approved examination of the disclosed utility of the invention claimed in an earlier patent to address the question of obviousness” and that “a later expiring patent is not patentably distinct from an earlier expiring patent if it merely claims a disclosed utility of the earlier claimed invention." Id. For example, when the claims in a later-expiring patent "merely recite methods of administering" the compositions claimed in the earlier patent, they are not patentably distinct over the claims of the earlier expiring patent." Id. (quoting Pfizer, Inc. v. Teva Pharms. USA, Inc., 86 USPQ2d 1001, 1008 (Fed. Cir. 2008)).
Furthermore, for double patenting of previously disclosed, but newly claimed utility, please see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010).
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
U.S. Patent No. 9,877,961
Claims 1-2, 4-5, 16-21 and 36-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 9,877,961 (‘961 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and claims of the ‘961 patent are similarly drawn to a compound of formula I. For example, the claims of the instant application are drawn to a compound of formula I (claims 1-2, 4-5, 16-20 and 36-37), a method for using a compound of formula I (claims 21) and a method for making diarginine piperazine (claims 38-42), whereas, the claims of the ‘961 patent are directed to: i) a method of using a compound of formula II (‘961 patent claims 1-3, 17-22); and ii) a kit comprising a compound of formula II ((‘961 patent claims 15-16), which is the same compound recited in instant claim 6 a piperazine compound of formula II, which is the same compound recited in instant claim 38 (see claim 17 of ‘961 patent).
Although the ‘961 patent is not explicit in claiming, for example, a compound of formula I, wherein A = a substituted piperazine, the claimed invention would have been obvious over the ‘892 application. This is because the ‘961 patent teaches a compound of formula I, wherein, A can be a substituted piperazine (see column 3) and teaches the compounds as anticoagulant reversal compounds (see abstract).
A patent’s "disclosure may be used…to answer the question whether claims merely define an obvious variation of what is earlier disclosed and claimed." AbbVie Inc. v. Mathilda & Terence Kennedy Inst. of Rheumatology Trust, 112 USPQ2d 1001, 1012 (Fed. Cir. 2014) (quoting In re Basell Poliolefine Italia S.P.A., 89 USPQ2d 1030, 1036 (Fed. Cir. 2008).
In the instant case, since the ‘961 patent discloses a compound of formula I, wherein A can be a substituted piperazine, as anticoagulant reversal compound (see discussions above), these aspects of the instant claims are, therefore, obvious over the ‘961 patent.
The AbbVie court explicitly noted that the Federal Circuit has “repeatedly approved examination of the disclosed utility of the invention claimed in an earlier patent to address the question of obviousness” and that “a later expiring patent is not patentably distinct from an earlier expiring patent if it merely claims a disclosed utility of the earlier claimed invention." Id. For example, when the claims in a later-expiring patent "merely recite methods of administering" the compositions claimed in the earlier patent, they are not patentably distinct over the claims of the earlier expiring patent." Id. (quoting Pfizer, Inc. v. Teva Pharms. USA, Inc., 86 USPQ2d 1001, 1008 (Fed. Cir. 2008)).
Furthermore, for double patenting of previously disclosed, but newly claimed utility, please see Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F.3d 1381, 1389 (2010).
Therefore, there is sufficient overlap between the claim scopes to render them obvious over each other. Consequently, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the reference application subject matter.
Conclusions
No claim is allowable.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicants should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should the Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IBRAHIM D BORI whose telephone number is (571)270-7020. The examiner can normally be reached on Monday through Friday 8:00AM-5:00PM(EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S LUNDGREN can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IBRAHIM D BORI/
Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629